Gilbert H. L. Tang, Matthew J. Price, Wolfgang Rottbauer, Paul D. Mahoney, Jorg Hausleiter, Philip W. Raake, William A. Rollefson, Philipp Lurz, Paolo Denti, Bassem K. Chehab, Melody Dong, Rong Huang, Federico M. Asch, Jose Luis Zamorano, Ralph Stephan von Bardeleben, Francesco Maisano, Saibal Kar, Evelio Rodriguez
- Background
Mitral transcatheter edge-to-edge repair (MTEER) is approved for patients with secondary mitral regurgitation (SMR) and heart failure based on COAPT (The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) eligibility criteria. Outcomes in patients beyond COAPT criteria with more advanced heart disease remain unclear.
Objectives
This study aimed to assess the outcomes of MTEER in SMR patients beyond COAPT trial criteria from the global, post-market EXPANDed studies.
Methods
Analyses were performed with the EXPANDed data set, including 2,205 patients treated with the 3rd/4th-generation MitraClip MTEER System. Non–COAPT-like patients were classified by baseline ≥3+ SMR and at least 1 of the following: left ventricular ejection fraction <20%, left ventricular end-systolic diameter >70 mm, or systolic pulmonary artery pressure >70 mm Hg. Echocardiographic outcomes were assessed by an echocardiographic core laboratory.
Results
Of the 967 SMR patientsBackground
Mitral transcatheter edge-to-edge repair (MTEER) is approved for patients with secondary mitral regurgitation (SMR) and heart failure based on COAPT (The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) eligibility criteria. Outcomes in patients beyond COAPT criteria with more advanced heart disease remain unclear.
Objectives
This study aimed to assess the outcomes of MTEER in SMR patients beyond COAPT trial criteria from the global, post-market EXPANDed studies.
Methods
Analyses were performed with the EXPANDed data set, including 2,205 patients treated with the 3rd/4th-generation MitraClip MTEER System. Non–COAPT-like patients were classified by baseline ≥3+ SMR and at least 1 of the following: left ventricular ejection fraction <20%, left ventricular end-systolic diameter >70 mm, or systolic pulmonary artery pressure >70 mm Hg. Echocardiographic outcomes were assessed by an echocardiographic core laboratory.
Results
Of the 967 SMR patients in EXPANDed, 197 were categorized as COAPT-like and 81 as non–COAPT-like. Both groups were elderly (74.4 ± 10.1 vs 73.6 ± 10.2 years) with a high prevalence of prior heart failure hospitalizations (HFH; 63% and 64%, respectively). Non–COAPT-like patients had larger left ventricular end-diastolic volumes (183 mL COAPT-like, 220 non–COAPT-like) and effective regurgitant orifice areas (0.33 cm2; 0.36). One-year mortality and HFH rates were similar between groups and comparable or lower to those in the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) and COAPT trials. HFH was reduced by 56% in COAPT-like and 74% in non–COAPT-like patients from pre- to post-MTEER. At 1 year, both groups achieved significant MR reduction (90% MR ≤1+ COAPT-like and non–COAPT-like).
Conclusions
In the EXPANDed studies, non–COAPT-like patients experienced significant improvements in MR, HFH, and quality-of-life at 1 year, comparable with those observed in COAPT-like patients. These findings suggest that MTEER may be an effective therapeutic option in appropriately selected patients outside COAPT eligibility. (The MitraClip EXPAND Study of the Next Generation of MitraClip Devices [EXPAND]; NCT03502811) (MitraClip EXPAND G4 Study [EXPAND G4]; NCT04177394)…
